Catheter balloon

Abstract

An expandable medical device or component thereof including a tubular body formed of a wrapped sheet of porous polymeric material fused together, the tubular body having a fused seam at an angle relative to the longitudinal axis of the tubular body which changes along the length of the tubular body from a first angle to a second angle greater than the first angle. The sheet of porous polymeric material is wound and then fused together such that the winding angle is less in a first longitudinal section of the tubular body compared with the winding angle in a second longitudinal section of the tubular body, in order to provide the second section with greater resistance to expansion (i.e., lower compliance) than the first section.

1. A balloon catheter, comprising:
 a) an elongated shaft having a proximal end, a distal end, and at least one lumen; and 
 b) a balloon having at least a first layer comprising a tubular body formed of a wrapped sheet of porous polymeric material fused together with a fused seam at an angle relative to the longitudinal axis of the shaft which changes along a length of the tubular body, and having a proximal skirt section and distal skirt section sealingly secured to the shaft so that the balloon interior is in fluid communication with the at least one lumen of the shaft, the entire length of the skirt sections being sealingly secured to the shaft such that the balloon has an inflatable section extending from the proximal skirt section to the distal skirt section, with the angle of the fused seam along at least one of the proximal and the distal skirt sections being greater than the angle of the fused seam along the entire length of the inflatable section between the sealingly secured skirt sections. 
 
   
   
     2. The balloon catheter of  claim 1  wherein the balloon has a second layer extending along the first layer and formed of a nonporous polymeric material. 
   
   
     3. The balloon catheter of  claim 1  wherein at least a portion of an inflatable working portion of the balloon has the fused seam at a first angle, at least a portion of the distal skirt section has the fused seam at a second angle, and at least a portion of the proximal skirt section has the fused seam at a third angle relative to the longitudinal axis, the second and third angles being about equal, and greater than the first angle. 
   
   
     4. The balloon catheter of  claim 1  wherein the balloon inflatable working portion is between a proximal and a distal inflatable portion, and at least a portion of the proximal and distal inflatable portions have the fused seam at an intermediate angle between the first angle and the second angle. 
   
   
     5. The balloon catheter of  claim 4  wherein the intermediate angle is about 20 to about 85 degrees. 
   
   
     6. The balloon catheter of  claim 4  wherein the first angle is about 20 to about 75 degrees. 
   
   
     7. The balloon catheter of  claim 1  wherein the second and third angles are each about 25 to about 89 degrees. 
   
   
     8. The balloon catheter of  claim 3  wherein the working portion of the balloon has a higher compliance at a given inflation pressure than inflatable portions of the balloon having the fused seam at a greater angle than the first angle. 
   
   
     9. The balloon catheter of  claim 3  wherein the fused seam at the first angle along at least a portion of the balloon working portion comprises abutted edges of the wrapped sheet fused together. 
   
   
     10. The balloon catheter of  claim 1  wherein the balloon is fused to the shaft, and has a burst pressure of about 250 to about 400 psi. 
   
   
     11. The balloon catheter of  claim 8  wherein the tubular body comprises multiple layers of the wrapped sheet, and adjacent layers of the wrapped sheet have the fused seam oriented in opposite directions.